A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01183598
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Duration (Months): 63
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or significant adverse events. Patients will receive their most effective maintenance dose until disease progression or significant toxicity occurs.

Condition or Disease	Intervention/Treatment	Phase
Castleman's Disease	Drug: tocilizumab [RoActemra/Actemra]	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm	Drug: tocilizumab [RoActemra/Actemra]; maintenance dose

Outcome Measures

Primary Outcome Measures

1. Efficacy: Maintenance of hemoglobin >/=10.5 g/dL, of Zubrod Performance Status, and of improvement in fatigue and anorexia as per National Cancer Institute Common Toxicity Criteria (NCI CTC) scales [until disease progression or significant toxicity occurs]

2. Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays [up to 90 days after discontinuation of treatment]

3. Provision of tocilizumab for treatment of Multicentric Castleman's Disease to patients with evidence of clinical benefit in response to tocilizumab [until disease progression or significant toxicity occurs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Evidence of improvement of one or more clinical benefit criteria with acceptable tolerability to RoActemra/Actemra in Protocol MRA001US, maintained clinical benefit in MRA004US, and completion of MRA004US

• Life expectancy > 12 weeks

• Zubrod performance status </= 3

Exclusion Criteria:

• Serious toxicity including anaphylactic reactions to tocilizumab during the MRA004US trial

• Any treatment for Multicentric Castleman's Disease except for corticosteroids within 2 weeks prior to Day 1

• Active infection requiring iv antibiotics for > 1 month and not resolving at least 1 week prior to Day 1; iv antibiotics prophylaxis for infections of implanted venous access portals is allowed

• Active viral infection within 28 days prior to Day 1

• Treatment with any investigational agent other than RoActemra/Actemra within 30 days prior to baseline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Little Rock	Arkansas	United States	72205-7199

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01183598
• Other Study ID Numbers: WA19847
• First Posted: Aug 17, 2010
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Castleman Disease

Study Results

No Results Posted as of Nov 2, 2016